Medical Device Software Process Improvement - A Perspective from a Medical Device Company

Marie Travers, Ita Richardson

2015

Abstract

When manufacturing medical devices there are many constraints that have to be taken into account such as safety, compliance with regulations and traceability. To do this, well-defined processes are used. With this in mind we examine how process improvement is implemented in a medical device company while managing the resultant change. The case study presented in this paper investigates the use of Kotter’s Change Model to support the implementation of process improvement in a medical device company. The results of the case study demonstrate that Kotter’s change model was an appropriate model to use. The sense of urgency Kotter stipulates was inherent in the company. The team was aware that change was needed. A flaw in Kotter’s approach is that there is no recommendation for a pilot project. Having a pilot project worked well for this company as it helped to eliminate stress and anxiety. A further case study is planned in the company to observe how the process is working after implementation of the full project.

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Paper Citation


in Harvard Style

Travers M. and Richardson I. (2015). Medical Device Software Process Improvement - A Perspective from a Medical Device Company . In Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015) ISBN 978-989-758-068-0, pages 462-469. DOI: 10.5220/0005223904620469


in Bibtex Style

@conference{healthinf15,
author={Marie Travers and Ita Richardson},
title={Medical Device Software Process Improvement - A Perspective from a Medical Device Company},
booktitle={Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015)},
year={2015},
pages={462-469},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0005223904620469},
isbn={978-989-758-068-0},
}


in EndNote Style

TY - CONF
JO - Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015)
TI - Medical Device Software Process Improvement - A Perspective from a Medical Device Company
SN - 978-989-758-068-0
AU - Travers M.
AU - Richardson I.
PY - 2015
SP - 462
EP - 469
DO - 10.5220/0005223904620469